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Approved, investigational, or neither: a status table for 27 peptides

One table, three statuses. Which peptides have an FDA-approved product, which are in a sponsor's trial program, and which have neither, with the compounding category and WADA line for each, as of September 21, 2026.

By Touchstone Peptides9 minute read

Of the 27 peptides and peptide-adjacent compounds on this page, eight are the active ingredient of an FDA-approved product, two are in a sponsor's Phase 3 program with no approval, and the remaining seventeen have neither a US approval nor a sponsor-run US program. "Approved" applies to a specific product from a specific company, never to a research vial of the same molecule. Every row below is checked against Drugs@FDA, FDA's compounding category lists, ClinicalTrials.gov or the WADA 2026 Prohibited List, as of September 21, 2026.

What the three statuses mean

Approved means Drugs@FDA lists a product whose active ingredient is that molecule, with an application number and an approval date. The approval belongs to the product and its sponsor. A vial of the same sequence bought from a research supplier is not that product, was not made under that application, and is not covered by it.

Investigational means a company is running registered trials under an investigational new drug application and has not received an approval. The trial drug is the sponsor's material, made and released under the sponsor's controls. Research vials sold under the same name are not the trial drug.

Neither means no product in Drugs@FDA and no sponsor-run US program. Most of the molecules people search for sit here. Many of them were nominated for FDA's 503A bulks list, which is a separate question from approval and is explained in 503A, 503B and research use only.

Two columns need a note. The 503A/503B column reports FDA's interim-policy categories: Category 1 is where FDA has said it does not intend to act against compounders who meet the guidance conditions; Category 2 is where FDA has identified significant safety concerns; "withdrawn" means the nominator pulled the nomination and the substance is now in no category at all. The WADA column reports where the 2026 Prohibited List names a substance. "Not named" is not a clearance: the List's S0 class and its "similar chemical structure or similar biological effect(s)" clauses are catch-alls, which is covered in WADA S0, S2 and strict liability.

Which peptides have an FDA-approved product?

PeptideClassApproved product (Drugs@FDA)503A/503B noteWADA 2026
SemaglutideGLP-1 receptor agonistOzempic, NDA 209637, Novo Nordisk, December 5, 2017; Rybelsus, NDA 213051, September 20, 2019; Wegovy, NDA 215256, June 4, 2021Compounding enforcement discretion during the shortage ended April 22, 2025 (503A) and May 22, 2025 (503B); see what ended for compounded semaglutide and tirzepatideNot named
TirzepatideGIP and GLP-1 receptor agonistMounjaro, NDA 215866, Eli Lilly, May 13, 2022; Zepbound, NDA 217806, November 8, 2023Discretion ended February 18, 2025 (503A) and March 19, 2025 (503B)Not named
LiraglutideGLP-1 receptor agonistVictoza, NDA 022341, Novo Nordisk, January 25, 2010; Saxenda, NDA 206321, December 23, 2014; generic ANDAs from December 2024FDA proposed on April 30, 2026 to exclude it, with semaglutide and tirzepatide, from the 503B bulks list; outcome not publishedNot assessed here
SermorelinGHRH(1-29) analogueGeref, NDA 020443, EMD Serono, September 26, 1997; marketing status Discontinued, which Drugs@FDA notes was not for safety or effectiveness reasonsOn FDA's 503B Category 1 list marked as a component of an approved drug; see sermorelin, tesamorelin, ipamorelin and CJC-1295S2.2.4, named
TesamorelinGHRH analogueEgrifta, BLA 022505, Theratechnologies, November 10, 2010; PrescriptionResearch "Tesamorelin" was cited as an unapproved new drug in FDA's August 2026 lettersS2.2.4, named
Bremelanotide (PT-141)Melanocortin receptor agonistVyleesi, NDA 210557, Cosette, June 21, 2019; PrescriptionResearch "PT-141" was cited as an unapproved new drug in the 2026 letters and appears on Import Alert 66-41's Red List; see Melanotan II and PT-141Not named
Afamelanotide (Melanotan I)Melanocortin receptor agonistScenesse, NDA 210797, Clivunel, October 8, 2019; PrescriptionNo category entry foundNot assessed here
Elamipretide (SS-31)Tetrapeptide amide (D-Arg-Dmt-Lys-Phe-NH2)Forzinity, NDA 215244, Stealth BioTherapeutics, September 19, 2025; PrescriptionResearch "SS-31" was cited as an unapproved new drug in the August 2026 lettersNot assessed here

Which peptides are investigational with no approval?

PeptideClassSponsor and stage503A/503B noteWADA 2026
RetatrutideGIP, GLP-1 and glucagon receptor agonistEli Lilly (LY3437943), Phase 3; for example NCT06383390 and NCT06859268 active, not recruitingNot on any 503A category list; named as an unapproved new drug in FDA's 2026 warning lettersNot named
CagrilintideAmylin analogueNovo Nordisk, Phase 3, co-formulated with semaglutide in the CagriSema program (NCT06131437 completed; NCT07564414 recruiting)Not on any category list; named in the March 31, 2026 CBP Cincinnati release; see cagrilintide is an amylin analogueNot named

A research vial labelled retatrutide is a catalog item with a sequence, a certificate and a lot number. It is not LY3437943 as made and released by its sponsor, and nothing on this site represents it as such. What investigational status means in practice is set out in retatrutide is investigational.

Which peptides have neither?

PeptideClassUS approval503A/503B note (as of September 21, 2026)WADA 2026
BPC-157PentadecapeptideNone. Only US-sited record is a University of Arkansas Phase 1, not yet recruiting (NCT07803250)503A Category 2 from September 29, 2023; nominations withdrawn, reflected April 22, 2026; not in Category 1; FDA staff proposed in July 2026 that it not be listedS0, named
TB-500 (thymosin beta-4 fragment LKKTETQ)Protein fragmentNone; only trial is a Hudson Biotech Phase 1/2 in China (NCT07487363)Withdrawn April 22, 2026; FDA proposed not to list; see TB-500 and thymosin beta-4 are not the same moleculeS2.3, "Thymosin-ß4 and its derivatives e.g. TB-500"
Thymosin alpha-1 (thymalfasin)N-acetylated peptide, MW 3108.3None; no thymalfasin entry in Drugs@FDA; US-sited trials are registered (SciClone Phase 3 studies in hepatitis C, completed) with no approved productOutside 503A Category 2 by September 27, 2024; listed as withdrawn April 22, 2026Not assessed here
KPVTripeptide, alpha-MSH(11-13)None; no ClinicalTrials.gov recordWithdrawn April 22, 2026; FDA proposed not to list; FDA: "FDA has not identified any human exposure data on drug products containing KPV"Not named
MOTS-c16-residue mitochondrial-derived peptideNone; only trial is Hudson Biotech Phase 2, China (NCT07505745)Withdrawn April 22, 2026; FDA proposed not to listS4.4.1, named as an AMPK activator
SemaxHeptapeptide, ACTH(4-7) analogueNone; no ClinicalTrials.gov recordWithdrawn April 22, 2026; FDA proposed not to listNot named
SelankHeptapeptide, tuftsin analogueNone; no ClinicalTrials.gov drug recordOutside 503A Category 2 by September 27, 2024; listed as withdrawn April 22, 2026, as "Selank acetate (TP-7)"Not named
EpitalonTetrapeptide AEDGNone; no ClinicalTrials.gov recordWithdrawn April 22, 2026; FDA proposed not to listNot named
DSIP (emideltide)NonapeptideNoneWithdrawn April 22, 2026; FDA proposed not to list; the only one of the seven July 2026 PCAC substances reported by press as voted downNot named
Kisspeptin-10DecapeptideNone; US Phase 1 records at Massachusetts General Hospital are withdrawnStill in 503A Category 2, added September 29, 2023S2.2.1, "kisspeptin and its agonist analogues"
CJC-1295GHRH analogue with a drug affinity complexNone; ConjuChem Phase 2 NCT00267527 terminatedOutside 503A Category 2 by September 27, 2024; listed as withdrawn April 22, 2026S2.2.4, named
IpamorelinPentapeptide amide (Aib-His-D-2-Nal-D-Phe-Lys-NH2), ghrelin receptor agonistNone; Helsinn Phase 2 trials completed (NCT01280344, NCT00672074)503B Category 2 since September 29, 2023, still listed; 503A nomination withdrawnS2.2.4, named among GHS
Melanotan IICyclic melanocortin agonistNone; only trial is Hudson Biotech Phase 2, China (NCT07437560)503A Category 2 from September 29, 2023, withdrawn April 22, 2026; on Import Alert 66-41's Red List (CanLab entry)Not named
AOD-9604Growth hormone C-terminal fragmentNone; no ClinicalTrials.gov recordOutside 503A Category 2 by September 27, 2024; listed as withdrawn April 22, 2026S2.2.3, "growth hormone fragments, e.g. AOD-9604"
GHK-CuCopper tripeptideNone as a drug; the only registered drug trial is a Hudson Biotech Phase 2 topical study in China (NCT07437586)503A Category 1 for all but one route of administration, in FDA's wording, re-added after May 5, 2026; the withdrawn route left Category 2 April 22, 2026; FDA intends to consult PCAC before the end of February 2027Not named
NAD+ (not a peptide)DinucleotideNo approved product; FDA's 503B Category 1 list carries it without the approved-component mark503A Category 1 as "Nicotinamide Adenine Dinucleotide (NAD)"Not named
5-amino-1MQ (not a peptide)Quinolinium small moleculeNone; no ClinicalTrials.gov recordNot on any 503A or 503B category listNot assessed here

The last two rows are included because NAD+ and 5-amino-1MQ sit on peptide shelves, including ours, and are asked about in the same breath. Neither is a chain of amino acids; which of these "peptides" are peptides explains both, and glutathione beside them.

What "withdrawn" means, and what it does not

Nine of the rows above changed on April 22, 2026, when FDA's Category 2 page moved twelve peptides to a section headed "nominated but withdrawn": a procedural event, not a safety finding, that leaves each substance in no category and off the 503A bulks list. The full sequence, including the July 2026 advisory committee meeting at which FDA staff proposed that seven of them not be listed, is in Category 1, Category 2 and the 503A bulks list, and the most-searched case is in BPC-157 in 2026.

Why an approved product and a research vial are not the same thing

Approval attaches to an application: a named sponsor, a manufacturing process, a specification, a label. Geref's approval from 1997 belongs to EMD Serono's product, and that product is discontinued. It says nothing about a vial of sermorelin sold as a research reagent, which is what we stock. The same is true of Vyleesi and a research vial of bremelanotide, and of Forzinity and a vial labelled SS-31.

This cuts the other way too. FDA's August 2026 warning letters cite sellers of research "Tesamorelin," "PT-141" and "SS-31" for marketing unapproved new drugs, even though an approved product with the same active ingredient exists. What made the research product a drug in FDA's reading was the seller's own text, which is the subject of what FDA reads before calling a research product a drug.

Reading the table

Use the first column to find the molecule, then read across. If the "approved product" cell names a product, that product is the only form of the molecule with an FDA approval. If the 503A/503B cell says "withdrawn" or "Category 2," no pharmacy pathway under section 503A exists for it today. If the WADA cell names a section, the substance is prohibited in sport at all times regardless of its FDA status. The full catalog, with each item's identity data, is at the catalog.

Sources

For laboratory research use only. Not a drug, not a supplement, and nothing here is a claim about what any of this material does in a person or an animal.

From the catalog

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